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Blood Flow in Individuals With Down Syndrome

Primary Purpose

Down Syndrome

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hand grip exercise and lower body negative pressure
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Down Syndrome focused on measuring exercise, blood flow, strength, blood pressure, heart rate,

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Between 18 and 45 years old
  • generally healthy
  • sedentary or low-active (defined as being involved in less than 30 minutes of moderately-intense physical activity per day)

  • additionally for the participants with Down syndrome:

    • diagnosis of Down syndrome trisomy 21 and
    • normal thyroid function or stable thyroid function (and medications) for at least 6 months.

Exclusion Criteria:

  • atherosclerotic or other vascular disease;
  • asthma or other pulmonary disease;
  • hypertension (defined BP >140/90 mmHg);
  • blood pressure below 90/60 mmHg;
  • history of pre-syncope or syncope;
  • diabetes (defined as Hba1c of >7.5% or use of glucose lowering medication);
  • severe obesity (defined as BMI >40);
  • medications affecting heart rate, blood pressure or arterial function;
  • anti-inflammatory medication including NSAIDS;
  • current smoking and
  • pregnancy.

Sites / Locations

  • Disability, Health, and Social Policy Building, Integrative Physiology Laboratory, Suite 158 at 1640 W. Roosevelt Rd

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Individuals with Down syndrome

Individuals without Down syndrome

Arm Description

For participants with Down syndrome, the first visit includes baseline measures and familiarization with the graded maximal exercise test protocol. If necessary, additional familiarization sessions will be scheduled for people with Down syndrome. The second visit, we perform the graded maximal exercise test and familiarize the participant with the procedures for the third visit: the hand grip exercise protocol and the lower body negative pressure (LBNP) box. The third visit we assess the peripheral blood flow during the hand grip exercise protocol without and with the LBNP. For control subjects, the first and second visit are combined. Their second visit is the same as the third visit for individuals with Down syndrome.

For participants with Down syndrome, the first visit includes baseline measures and familiarization with the graded maximal exercise test protocol. The second visit, we perform the graded maximal exercise test and familiarize the participant with the procedures for the third visit: the hand grip exercise protocol and the lower body negative pressure (LBNP) box. The third visit we assess the peripheral blood flow during the hand grip exercise protocol without and with the LBNP. For control subjects, the first and second visit are combined. Their second visit is the same as the third visit for individuals with Down syndrome.

Outcomes

Primary Outcome Measures

Brachial blood flow
Forearm blood flow and vascular conductance will be measured in both the exercising and non-exercising arm using high definition ultrasound (Alpha 7, Aloka-Hitachi). The brachial artery will be imaged in dual mode allowing for simultaneous determination of artery diameter (B-mode) and flow velocity (Doppler mode). Blood flow will be determined from the following formula: Forearm Blood flow = (Mean blood velocity) x (Brachial Cross Sectional Area) x (60) and expressed as ml/min. Forearm vascular conductance will be determined by dividing forearm blood flow by mean arterial pressure. Forearm blood flow and vascular conductance will be normalized to forearm lean mass to account for differences in lean mass between individuals.

Secondary Outcome Measures

Muscle oxygenation
Muscle oxygenation will be measured with near-infrared spectography (NIRS), which is a simple, noninvasive method for measuring the presence of oxygen in muscle. It can monitor changes in muscle oxygenation and blood flow during submaximal and maximal exercise. During exercise, the extent to which skeletal muscles deoxygenate varies according to the type of muscle, type of exercise and blood flow response.
Cardiac outut
Cardiac output will be measured during a graded maximal test protocol using ultrasonography, by measuring the aortic diameter at the level of the valve form the peristernal long axis. Ascending aortic blood flow will be measured using continuous Doppler echocardiography using a pedoff probe in the suprasternal notch.

Full Information

First Posted
June 21, 2018
Last Updated
July 11, 2019
Sponsor
University of Illinois at Chicago
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03590665
Brief Title
Blood Flow in Individuals With Down Syndrome
Official Title
Central & Peripheral Blood Flow Regulations in Individuals With Down Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
PI accepted a position at a new Institution and terminated the study at UIC.
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
May 8, 2019 (Actual)
Study Completion Date
May 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study focuses on physiological explanations of difficulties with physical activity and exercise in individuals with Down syndrome, by non-invasively examining cardiac output and the regulation of blood flow to working muscles during exercise.
Detailed Description
Work capacity is an important predictor of declining health or physical function, and of mortality, and is commonly measured as peak oxygen consumption. Peak oxygen consumption is very low in individuals with Down syndrome, the most prevalent genetic cause of intellectual disability. Previous research suggests individuals with Down syndrome may experience a double disadvantage when they are exercising: they may not be able to increase cardiac output sufficiently and they may not be able to allocate adequate blood flow to the working muscles. The aim of this research study is therefore to determine the impact of limitations in central and peripheral regulation of blood flow on work capacity in individuals with DS. The results of this project will aid our understanding of the underlying mechanisms and determine the potential to improve health across the lifespan of individuals with Down syndrome by tailoring exercise interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
exercise, blood flow, strength, blood pressure, heart rate,

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The acute response to exercise in blood flow is non-invasively assessed in group of individuals with Down syndrome and a control group of age- and sex-matched individuals without Down syndrome.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individuals with Down syndrome
Arm Type
Other
Arm Description
For participants with Down syndrome, the first visit includes baseline measures and familiarization with the graded maximal exercise test protocol. If necessary, additional familiarization sessions will be scheduled for people with Down syndrome. The second visit, we perform the graded maximal exercise test and familiarize the participant with the procedures for the third visit: the hand grip exercise protocol and the lower body negative pressure (LBNP) box. The third visit we assess the peripheral blood flow during the hand grip exercise protocol without and with the LBNP. For control subjects, the first and second visit are combined. Their second visit is the same as the third visit for individuals with Down syndrome.
Arm Title
Individuals without Down syndrome
Arm Type
Other
Arm Description
For participants with Down syndrome, the first visit includes baseline measures and familiarization with the graded maximal exercise test protocol. The second visit, we perform the graded maximal exercise test and familiarize the participant with the procedures for the third visit: the hand grip exercise protocol and the lower body negative pressure (LBNP) box. The third visit we assess the peripheral blood flow during the hand grip exercise protocol without and with the LBNP. For control subjects, the first and second visit are combined. Their second visit is the same as the third visit for individuals with Down syndrome.
Intervention Type
Other
Intervention Name(s)
Hand grip exercise and lower body negative pressure
Intervention Description
For participants with Down syndrome, the first visit includes baseline measures and familiarization with the graded maximal exercise test protocol. If necessary, additional familiarization sessions will be scheduled for people with Down syndrome. The second visit, we perform the graded maximal exercise test and familiarize the participant with the procedures for the third visit: the hand grip exercise protocol and the lower body negative pressure (LBNP) box. The third visit we assess the peripheral blood flow during the hand grip exercise protocol without and with the LBNP. For control subjects, the first and second visit are combined. Their second visit is the same as the third visit for individuals with Down syndrome.
Primary Outcome Measure Information:
Title
Brachial blood flow
Description
Forearm blood flow and vascular conductance will be measured in both the exercising and non-exercising arm using high definition ultrasound (Alpha 7, Aloka-Hitachi). The brachial artery will be imaged in dual mode allowing for simultaneous determination of artery diameter (B-mode) and flow velocity (Doppler mode). Blood flow will be determined from the following formula: Forearm Blood flow = (Mean blood velocity) x (Brachial Cross Sectional Area) x (60) and expressed as ml/min. Forearm vascular conductance will be determined by dividing forearm blood flow by mean arterial pressure. Forearm blood flow and vascular conductance will be normalized to forearm lean mass to account for differences in lean mass between individuals.
Time Frame
In minute 4 of the 5-minute bout of grip strength exercise
Secondary Outcome Measure Information:
Title
Muscle oxygenation
Description
Muscle oxygenation will be measured with near-infrared spectography (NIRS), which is a simple, noninvasive method for measuring the presence of oxygen in muscle. It can monitor changes in muscle oxygenation and blood flow during submaximal and maximal exercise. During exercise, the extent to which skeletal muscles deoxygenate varies according to the type of muscle, type of exercise and blood flow response.
Time Frame
In minute 4 of the 5-minute bout of grip strength exercise
Title
Cardiac outut
Description
Cardiac output will be measured during a graded maximal test protocol using ultrasonography, by measuring the aortic diameter at the level of the valve form the peristernal long axis. Ascending aortic blood flow will be measured using continuous Doppler echocardiography using a pedoff probe in the suprasternal notch.
Time Frame
Every second minute until the 12th minute of the maximal test.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between 18 and 45 years old generally healthy sedentary or low-active (defined as being involved in less than 30 minutes of moderately-intense physical activity per day) additionally for the participants with Down syndrome: diagnosis of Down syndrome trisomy 21 and normal thyroid function or stable thyroid function (and medications) for at least 6 months. Exclusion Criteria: atherosclerotic or other vascular disease; asthma or other pulmonary disease; hypertension (defined BP >140/90 mmHg); blood pressure below 90/60 mmHg; history of pre-syncope or syncope; diabetes (defined as Hba1c of >7.5% or use of glucose lowering medication); severe obesity (defined as BMI >40); medications affecting heart rate, blood pressure or arterial function; anti-inflammatory medication including NSAIDS; current smoking and pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thessa Hilgenkamp, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Disability, Health, and Social Policy Building, Integrative Physiology Laboratory, Suite 158 at 1640 W. Roosevelt Rd
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Blood Flow in Individuals With Down Syndrome

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